## α and 1–β [Power / Sample Size]

Hi Helmut,

» Although the study was performed with 28 subjects for ~81% power, the chance to get a post hoc power of ≥ 90% is ~23% and ≥ 95% is ~10%. That’s clearly not “forced BE” and none of these studies should be questioned by regulators.

You are considering the power after the study at n = 28 (which were calculated before the study: GMR=0.95, CV=0.25, β=0.80). The question is whether it is possible to carry out a study at n = 50 and will this be forced bioequivalence?
Regards